In a first, FDA allows a 'psychedelic without the trip' to be tested at home

Delix Therapeutics, which is developing a psychedelic-like drug for depression, reported promising early data this morning and said that for its next trial, the FDA will allow patients to take the drug — designed to not be hallucinogenic — at home.

Several drugs containing psychedelic compounds like psilocybin and LSD are now in late-stage development, but because they are hallucinogenics, patients are required to take them in specialized clinics and be monitored for hours. That would make the offerings logistically challenging and expensive to administer if they go on the market.

Drugs like Delix’s, called neuroplastogens, are designed to exert the same rapid and enduring therapeutic benefits as classic psychedelics but without the “trip.”

gene therapy

BioMarin looks to divest hemophilia A therapy

BioMarin Pharmaceutical said late yesterday when reporting earnings that it's planning to remove its hemophilia A gene therapy Roctavian from its portfolio.

The biotech is assessing out-licensing options, saying “this decision is consistent with BioMarin's portfolio strategy and offers the most promising opportunity for ensuring continued patient access.”

BioMarin originally hoped patients would seek out its one-time therapy, but it's struggled since its launch. Patients have been reluctant to switch from effective chronic treatments to a gene therapy that's complex to administer.

drug pricing

Cigna to end drug rebates for many commercial plans

Cigna said yesterday it will get rid of drug rebates for many of its private health plans starting in 2027 and instead make discounts available up front.

The news comes as President Trump pursues his stated goal of lowering drug prices. Though his policies so far have focused on getting pharma companies to change their pricing and business practices, he and his officials have repeatedly criticized PBMs for contributing to high costs in the U.S.

In its announcement, Cigna said “we applaud President Trump and his Administration for taking decisive action to help lower costs for brand-name medicines that have long been controlled by drug companies.”

The move by Cigna, which owns one of the three big PBMs in the U.S., could have ripple effects on its peers. Health secretary Robert F. Kennedy Jr. praised Cigna's announcement on X and called on other companies urge “to join President Trump in putting Americans first.”

Typically, employers will pay the full price of medications first and get rebates from drugmakers later, but Cigna's new model of offering up-front discounts gives employers “more real-time visibility into their drug costs, improving their ability to support their population and forecast their budgets,” the company said.

Cigna also said it will create a system in which patients will have access to the lowest available price of a medication when they fill their prescription, whether it be their copay, a cash price offered by the drugmaker, or any other price.

biotech

Intellia faces an existential threat

After Intellia Therapeutics said yesterday it's pausing two late-stage CRISPR gene-editing trials after a patient was hospitalized with liver damage, it's now difficult to imagine a viable future for the company, my colleague Adam Feuerstein writes.

Intellia possibly would have been able to manage the safety risk if it were were pursuing fatal diseases without treatment options. But both of the company’s lead programs are in diseases — transthyretin amyloidosis and hereditary angioedema — in which recently approved drugs have proven to be highly effective.

The biotech's stock plunged 42% yesterday.

C-SUITE

Organon CEO resigns after wholesaler probe

Organon, the drugmaker focused on women's health products, said yesterday its CEO, Kevin Ali, will resign after the board discovered “improper” wholesaler sales practices related to its contraceptive Nexplanon.

The company said certain U.S. wholesalers were asked to buy more Nexplanon than needed in recent years. The sales represented less than 1% of the company's revenue in those years, but enabled it to meet guidance or certain revenue expectations, Organon said.

The firm fired its head of U.S. commercial and government affairs as part of the probe, and said there has been no finding that the chief financial officer was aware of the practices.

Organon has appointed Joseph Morrissey, its head of manufacturing and supply, as interim CEO.

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